Preterm InfantsNCT03252327
Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes
A study testing Multiple Sensory Integrations in people with Preterm Infants and Pain, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. Read more about this study
- Who is it for?
- Ages 3 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants, Pain
- What is being tested?
- Multiple Sensory Integrations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age (GA) 28-37 weeks
- Post-menstrual age (PMA) 29-38 weeks
- Postnatal age 3-28 days
- Sable condition (NTISSscore ≦ 22)
- Apgar scores≧7 at 5 minutes after birth
Who cannot join
- Neurologic impairment
- Congenital anomalies
- Surgery
- Severe growth restriction at birth
- Severe medical conditions requiring treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures
Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. It becomes important, therefore, to relieve preterm infants' pain and distress using multiple sensory integrations during peripheral venous puncture procedures.The proposed 2-year study has specific aim: to compare the effects of different combination of sensory integrations on preterm infants' pain and distress before, during, and after peripheral venous puncture procedures.
- Conditions
- Preterm Infants, Pain
- Being tested
- Multiple Sensory Integrations
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Sensory IntegrationsOther
breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.
| Study group | Role | What they receive |
|---|---|---|
| routine care | No intervention | Preterm infants in the control condition will receive only usual neonatal intensive care units (NICU) care |
| Multiple Sensory Integrations(1) | Experimental | The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile). Receives: Other: Multiple Sensory Integrations |
| Multiple Sensory Integrations(2) | Experimental | The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile). Receives: Other: Multiple Sensory Integrations |
| Multiple Sensory Integrations(3) | Experimental | The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile). Receives: Other: Multiple Sensory Integrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm infants' pain
Premature Infant Pain Profile-Revised (PIPP-R) for pain, A score <7 suggests no or little pain, 7-12 mild to moderate pain and scores >12 indicate moderate to severe pain.
Measured: 20-30 minutes (during peripheral venous puncture procedures)
Secondary outcomes (5)
preterm infants' physiological parameters:heart rate
Heart rate will be recorded from ECG leads. Heart rate in beats per minute (mean of physiological parameters)
Measured: 20-30 minutes (during peripheral venous puncture procedures)
Preterm infants' physiological parameters:respiration rate
Respiration rate will be recorded from ECG leads. Respiration rate in breaths per minute. (mean of physiological parameters)
Measured: 20-30 minutes (during peripheral venous puncture procedures)
Preterm infants' physiological parameters: oxygen saturation
Oxygen saturation will be recorded from ECG leads. Oxygen saturation in % (mean of physiological parameters)
Measured: 20-30 minutes (during peripheral venous puncture procedures)
preterm infants' behavioral responses
The infant behavioral responses will be measured by using an infant behavioral coding scheme. Behavioral data during venous puncture procedures will be collected using a real-time colour video recorder. Frequency ratios for pain and distress behaviors, include: facial activity (e.g. brow bulge, eye squeeze, nasolabial furrow), body movement, cry, transition between sleep and wake states.
Measured: 20-30 minutes (during peripheral venous puncture procedures)
preterm infants' duration of fussing and cry
Fussing and crying will be record from the recording pen in minutes.
Measured: 20-30 minutes (during peripheral venous puncture procedures)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start26 Aug 2017
- Primary completion1 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Hsiang-Ping Wu, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252327
- Sponsor's protocol ID
- 2-106-05-080
- Status last verified
- May 2019
- First submitted
- 8 Aug 2017
- Last updated
- 13 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures
- ClinicalTrials.gov ID
- NCT03252327
- Acronym / sponsor ID
- 2-106-05-080
- Conditions
- Preterm Infants, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 26 Aug 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. It becomes important, therefore, to relieve preterm infants' pain and distress using multiple sensory integrations during peripheral venous puncture procedures.The proposed 2-year study has specific aim: to compare the effects of different combination of sensory integrations on preterm infants' pain and distress before, during, and after peripheral venous puncture procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| routine care | No intervention | –Preterm infants in the control condition will receive only usual neonatal intensive care units (NICU) care |
| Multiple Sensory Integrations(1) | Experimental | Other: Multiple Sensory IntegrationsThe sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile). |
| Multiple Sensory Integrations(2) | Experimental | Other: Multiple Sensory IntegrationsThe sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile). |
| Multiple Sensory Integrations(3) | Experimental | Other: Multiple Sensory IntegrationsThe sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile). |
Who may qualify
- Ages
- 3 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age (GA) 28-37 weeks
- Post-menstrual age (PMA) 29-38 weeks
- Postnatal age 3-28 days
- Sable condition (NTISSscore ≦ 22)
- Apgar scores≧7 at 5 minutes after birth
Key exclusion criteria (5 listed)
- Neurologic impairment
- Congenital anomalies
- Surgery
- Severe growth restriction at birth
- Severe medical conditions requiring treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Sensory Integrationsbreast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking. | Other | Multiple Sensory Integrations(1), Multiple Sensory Integrations(2), Multiple Sensory Integrations(3) |
Primary outcome
Preterm infants' pain
Time frame: 20-30 minutes (during peripheral venous puncture procedures)
Premature Infant Pain Profile-Revised (PIPP-R) for pain, A score <7 suggests no or little pain, 7-12 mild to moderate pain and scores >12 indicate moderate to severe pain.
5 secondary outcomes
preterm infants' physiological parameters:heart rate
Time frame: 20-30 minutes (during peripheral venous puncture procedures)
Preterm infants' physiological parameters:respiration rate
Time frame: 20-30 minutes (during peripheral venous puncture procedures)
Preterm infants' physiological parameters: oxygen saturation
Time frame: 20-30 minutes (during peripheral venous puncture procedures)
preterm infants' behavioral responses
Time frame: 20-30 minutes (during peripheral venous puncture procedures)
preterm infants' duration of fussing and cry
Time frame: 20-30 minutes (during peripheral venous puncture procedures)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Sensory Integrations in people with Preterm Infants and Pain, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm infants' pain (time frame: 20-30 minutes (during peripheral venous puncture procedures)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.